← Back to catalogue

Baby Gorilla®/Gorilla® Plating System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
Baby Gorilla®/Gorilla® Plating System FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
Posterior Straddle Plate, TTC, Contoured, Long, Right, 16-Hole, TiA FDA UDI
Model / Reference
P53-413-R112 FDA UDI
Description
Posterior Straddle Plate, TTC, Contoured, Long, Right, 16-Hole, TiA FDA UDI

Identifiers

Catalog Number
P53-413-R112 FDA UDI
Primary DI / UDI-DI
00889795112231 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 7fbdf001-63ea-4df8-8920-b66377965ed2 34 fields · synced Jun 1, 2026